ECMO Circuit Pressure Alarm PROJECT PROPOSAL

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ECMO Circuit Pressure AlarmPROJECT PROPOSAL
University of Pittsburgh Senior Design - BioE1160

• Desiree Bonadonna
• Apryle Craig
• Laura Gilmour

ECMOre, Uninc.
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Overview

• ECMO Pressure Alarm
• Pre-Oxygenator
• Post-Oxygenator
• Post-Heat Exchanger
• Audible and Visual Alarms
• Make healthcare workers aware of high/low
  pressures
• Dangers of high/low pressures
• Healthcare Workers
• Perfusionists
• ECMO Technicians
• Physicians
• Nurses
• Redesign
• Analog ? Digital
• Programmable
• Audible Alarm
• Add additional pressure indicator (post
  heat-exchanger)

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Project Goals

• Develop digital pressure alarm system
• Simulink model
• Build model
• Submission for FDA approval
• Milestones
• Current technology summary
• Re-assess project goals
• Redesign
• Add programmable inputs
• Add alarm
• Add sound
• Deliverable

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Features Benefits

• Three inputs
• Monitor pressure pre- and post-oxygenator
• Monitor pressure pre- and post-heat exchanger
• Digital System
• Reduce interpretation errors
• Clear and easy to understand
• Consistency
• Three read-outs
• Clear display of each pressure
• Three pressures can be monitored and compared at
  same time

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Features Benefits

• Programmable range
• Adjust high and low alarm range per patient basis
• Allows for variable sensitivity of system
• Audible and Visual Alarms
• Alert staff by audible alarm
• Notify particular pressure deviance by visual
  alarm

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Description Circuit Modification
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Description Device Circuitry
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Design Alternatives

• Types of Displays
• Number of Audible Alarms
• Number of Visual Alarms
• Alarm independence/convenience

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Competitive Analysis

• Current Medically approved devices
• Analog
• Difficult to read
• Not clearly labeled
• No audible
• No visual alarm
• Non-approved devices
• Digital with visual alarm

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Competitive Analysis

• ECMOre Design weaknesses
• More expensive than analog
• More tubing in an already cluttered space
• Increased training time/expenses

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Technology

• Altera circuit design software
• SolidWorks for enclosure
• SimuLink
• Model an ECMO circuit using water
• Experiment with transducer voltages
• Test final product

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Team/Resources

• Team
• Desiree Bonadonna- Design Manager
• Apryle Craig- Electronics Manager
• Laura Gilmour- Standards Manager
• Michael Shaeffer- Project Advisor
• Steven Jacobs, PhD- Circuitry Advisor
• Equipment
• Electronics ordered from University Vendor
• Tools/signal generators available in B69

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Team/Resources

• Locations
• Instrumentation Laboratory- B69 Benedum
• Design Laboratory- B62 Benedum
• Healthcare consultation- Childrens Hospital of
  Pittsburgh
• Manufacturing
• UPMC Machine Shop (Scaiffe Hall)
• UPMC Electronics Shop (Scaiffe Hall)
• Funding
• University of Pittsburgh Department of
  Bioengineering

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Schedule
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Team Roles
Name Role Tasks
Desiree Bonadonna Design Manager Oversee product design Reassess design at appropriate times
Apryle Craig Electronics Manager Oversee circuitry design Electronics ordering and production
Laura Gilmour Standards Manager Oversee communications Ensure designs meet FDA standards/are eligible for approval
Steven Jacobs, PhD Project Advisor Electronics consultant Provide guidance in design procedure
Michael Shaeffer Project Advisor Healthcare consultant Provide guidance in design procedure
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Current Status

• Met with both advisors
• Visited Childrens ECMO services
• HFE Analysis, FMEA
• Determined regular meeting time for next semester

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Acknowledgements

• University of Pittsburgh
• Department of Bioengineering
• Mark Gartner
• Michael Shaeffer
• Steven Jacobs

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Questions?